510k
Database
Specialties
Anesthesiology
338
Cardiovascular
1076
Chemistry
273
Dental
827
Ear, Nose, Throat
149
Gastroenterology & Urology
639
General & Plastic Surgery
1339
General Hospital
778
Hematology
100
Immunology
72
Medical Genetics
1
Microbiology
369
Neurology
591
Obstetrics & Gynecology
249
Ophthalmic
159
Orthopedic
2068
Pathology
40
Physical Medicine
314
Radiology
1601
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
209
QIH
Automated Radiological Image...
208
LLZ
System, Image Processing,...
200
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
170
NHA
Abutment, Implant, Dental,...
162
NKB
Thoracolumbosacral Pedicle Screw...
138
MAX
Intervertebral Fusion Device...
138
Browse all 339 categories →
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Mallinckrodt Group, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Mallinckrodt Group, Inc. - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 1976
Official Website
27
Total
27
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mallinckrodt Group, Inc.
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
May 19, 1995
LF CT HIG PRESSURE CATHETERS
K945053
·
FOZ
General Hospital
·
217d
Cleared
Sep 07, 1994
SURGICAL DRAPES
K943122
·
KKX
General Hospital
·
70d
Cleared
May 24, 1994
HYDRAGOWN
K934664
·
FYA
General Hospital
·
238d
Cleared
Aug 10, 1990
DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST
K902446
·
FMW
General Hospital
·
70d
Filters
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All
27
Radiology
13
Cardiovascular
6
General Hospital
4
Gastroenterology & Urology
3
Pathology
1